NCT06826755

Brief Summary

The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2025Jan 2027

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

February 10, 2025

Last Update Submit

November 19, 2025

Conditions

PerimenopauseHypertension

Outcome Measures

Primary Outcomes (2)

  • Change in Nocturnal Systolic Blood Pressure (SBP)

    Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.

    Measured at baseline and at the end of the 12-week intervention

  • Change in Nocturnal Diastolic Blood Pressure (DBP)

    Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.

    Measured at baseline and at the end of the 12-week intervention.

Secondary Outcomes (1)

  • Change in Oxidative Stress Markers

    Measured at baseline and at the end of the 12-week intervention.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler.

Dietary Supplement: Placebo

Melatonin

OTHER

Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women.

Dietary Supplement: Terry Naturally® melatonin 5mg SR

Interventions

Terry Naturally® melatonin 5mg SRDIETARY_SUPPLEMENT

Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

Melatonin
PlaceboDIETARY_SUPPLEMENT

Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

Placebo

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-55 years old
  • Female individuals with intact uterus and at least one ovary
  • Hypertension
  • o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
  • On stable medical regimen (≥ 2 months) if taking other medications

You may not qualify if:

  • Prescription sleeping medications or melatonin supplementation
  • Pregnant or lactating
  • Use of tobacco, nicotine or vaping products
  • Night shift work
  • On prescription aspirin
  • Severe lactose intolerance
  • History of substance use disorder
  • History of suicidal ideation
  • History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
  • Active cancer
  • Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale \[ESS\])81
  • Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
  • Inability to provide written consent and/or to speak and read English
  • Any other medical, geographic, or social factor making study participation impractical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Naima Covassin, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Perimenopause Study Team

CONTACT

507-255-8897PerimenopauseStdy@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

May 23, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)